Taiwan FDA registration 42ef4acee5503f3a8defc147a0ee71e6

Qizhe prostate-specific antigen in vitro reagent set

TW: 啟哲前列腺特異性抗原體外試劑組

Taiwan·Risk Class 2·Longteng Biotechnology Co., Ltd·Registered Dec 11, 2013 – Dec 07, 2016Cancelled

Registration details

Analysis ID: 42ef4acee5503f3a8defc147a0ee71e6

Company information

Manufacturer: Longteng Biotechnology Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Qizhe Biotechnology Co., Ltd

Product details

Intended Use: Qualitative detection of prostate-specific antigen (PSA) in human serum and blood.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.6010 腫瘤相關抗原免疫試驗系統
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Dec 11, 2013
Expiry Date: Dec 07, 2016
Cancellation Date: Apr 25, 2018

Cancellation information

Status: Logged out
Reason: 自行鍵入

About this record

Access comprehensive regulatory information for Qizhe prostate-specific antigen in vitro reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 42ef4acee5503f3a8defc147a0ee71e6 and manufactured by Longteng Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.

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